Recruiting

Allay™ Hydrogel Cap

Sponsor:

Tulavi Therapeutics,Inc.

Code:

NCT07246980

Conditions

Peripheral Nerve Injuries

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Nerve Cap

Study Details

Brief summary:

is is a multi-center, open-label, observational registry study (both prospective and retrospective) designed to evaluate the safety and performance of the allay™ Hydrogel Cap. This cap is an in situ forming implantable hydrogel medical device used in various peripheral nerve surgeries, including amputation and neuroma excision.

The study aims to gather demographic, operative, and clinical outcomes data from patients who have received the device.

The primary endpoints focus on the device's clinical performance, assessed using patient-reported outcomes (PROs). These include tracking changes in pain scores, pain intolerance, and cold intolerance, as well as the incidence of neuroma recurrence and changes in pain medication use from baseline.

Secondary endpoints concentrate on safety, monitoring the incidence of device failures, surgical complications, unplanned re-operations, and unexpected adverse device events (UADEs) within the study population. Essentially, the registry is collecting real-world data to determine how well and how safely the allay™ cap performs in a clinical setting.

Conditions

Peripheral Nerve Injuries

Study ID

NCT07246980

Start date

May 6, 2026

Status verified date

Jun, 2026

Completion date

May 1, 2029

Anticipated

Primary completion date

Jan 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients who have or will receive allay™ Hydrogel Cap

Exclusion Criteria:

  • Patients who have not received allay™ Hydrogel Cap

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Interventions

Nerve Cap

Patients who have or will receive allay Hydrogel Cap

Primary outcome measure

  • Assessment of change in Pain Scores from baseline using VAS [ Time Frame: Baseline (Pre Surgery ), 2 Weeks, 1 month, 4 month, 12 month and 24 month (Post Surgery) ]
  • Assessment of change in Pain scores from baseline using Numerical Rating Scale [ Time Frame: Baseline (Pre Surgery ), 2 Weeks, 1 month, 4 month, 12 month and 24 month (Post Surgery) ]
  • Assessment of change in Pain Interference from baseline using PROMIS PI Short Form 5b [ Time Frame: Baseline (Pre Surgery ), 2 Weeks, 1 month, 4 month, 12 month and 24 month (Post Surgery) ]
  • Assessment of change in Neuropathic Pain Quality from baseline using Patient-Reported Outcome Measurement Information System (PROMIS) v2.0 Neuropathic Pain Quality 5a [ Time Frame: Baseline (Pre Surgery ), 2 Weeks, 1 month, 4 month, 12 month and 24 month (Post Surgery) ]
  • Assessment of change in Cold Intolerance from baseline using Cold Intolerance Symptom Severity (CISS) score [ Time Frame: Baseline (Pre Surgery ), 2 Weeks, 1 month, 4 month, 12 month and 24 month (Post Surgery) ]
  • Assessment of change from baseline in the average quantity of pain medication taken via the Medication Quantification Scale (MQS) at 12 months. [ Time Frame: Baseline (Pre Surgery ), 2 Weeks, 1 month, 4 month, 12 months (Post Surgery) ]

Central Contacts and Locations

Locations

Orlando Health

Recruiting

Orlando, Florida, United States, 32806

Contacts

Nicollete Clouser

321-843-5687nicollete.clouser@orlandohealth.com

Principal Investigator:

Dr. Karan Desai

Florida Orthopedic Institute

Recruiting

St. Petersburg, Florida, United States, 33702

Contacts

Dr. Dzi-Viet Nguyen, DO

(727) 527-5272dnguyen@floridaortho.com

katie Foss

727-369-4994kfoss@floridaortho.com

Principal Investigator:

Dzi-Viet Nguyen, DO

Complete Foot and Ankle Care of North Texas, PA

Recruiting

Denton, Texas, United States, 33702

Contacts

Damien Dauphinee, DPM

972-896-9611dmdsurgery@gmail.com

Siobhan Cemper

(940) 300-3054scemper@completefootandanklcare.com

Principal Investigator:

Damien Dauphinee, DPM

More Information

Sponsor

Tulavi Therapeutics,Inc.

Last update posted

Jul 23, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Tulavi Therapeutics,Inc. on 2026-07-23.